Senior Principal Scientist, Regulatory Liaison
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Job Description
Senior Principal Scientist leading global regulatory strategies for Merck’s immunology drug and biologic programs. Guiding submissions, health-authority interactions, labeling, and product approvals worldwide.
Responsibilities:
- Develop and implement worldwide regulatory strategies for assigned General Medicine projects, with a focus on Immunology development programs
- Provide regulatory oversight to optimize product labeling and obtain the shortest time to approval from global regulatory agencies
- Independently manage projects as the accountable global point of contact for project teams
- Interact with worldwide regulatory agencies and subsidiaries regarding global regulatory strategy and registration requirements
- Use regulatory and competitive landscapes to establish strategies that facilitate speed-to-market and targeted product labeling
- Serve as Global Regulatory Lead and regulatory single point of contact throughout product life cycles
- Lead Global Regulatory Teams coordinating cross-functional regulatory support
- Coordinate preparation, submission, and follow-up communications with regulatory agencies
- Review global applications and associated documentation
- Review and provide final approval of local registration study protocols for secondary markets
- Lead regulatory meetings, teleconferences, and written communications with agencies including FDA and EMA
- Lead cross-functional preparation for FDA advisory committees
- Review worldwide marketing applications, clinical study reports, protocols, and investigator brochures
- Prepare INDs/CTAs for global studies involving investigational drugs and biologics
- Participate in regulatory due diligence for licensing candidate reviews
Requirements:
- B.S. or M.S. with a minimum of 10 years of relevant drug development experience, with the majority in regulatory, OR M.D. or PhD/PharmD with a minimum of 7 years of relevant drug development experience, including five years in regulatory
- Experience leading or supporting direct interactions with major Health Authorities, such as FDA and EMA
- Expertise leading regulatory strategies across global regions
- Global regulatory affairs experience in major markets: U.S., EU, Japan, and China
- Strategic thinking, problem-solving, and continuous learning mindset
- Effective written and verbal communication, with ability to influence, lead, and negotiate across levels and functions
- Leadership experience building and leading high-performing teams or projects
- Corporate and ethical integrity
- Preferred: therapeutic area expertise in immunology
- Preferred: small and large molecule experience
- Preferred: prior people management experience
- Required skills: Drug Development, Global Regulatory, Pharmaceutical Industry, Pharmaceutical Research, Product Registrations, Regulatory Affairs Management, Regulatory Communications, Regulatory Documents, Regulatory Processes, Regulatory Strategies, Regulatory Strategy Development, Regulatory Submissions, Strategic Leadership
- US and Puerto Rico residents only
- No visa sponsorship
Benefits:
- Annual bonus
- Long-term incentive, if applicable
- Medical, dental, and vision healthcare
- Other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate days
- Sick days
- Remote work arrangement
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